• Patients receiving CardiAMP cell therapy had a 37% relative risk reduction of cardiac mortality equivalents (death, heart transplantation, left ventricular assist device implantation) and fewer major non-fatal cardiac and cerebrovascular adverse events at an average age of 20 years. (MACCE) relative risk decreased by 9%. – 1 month follow-up compared to control patients who received only guideline-based cardiac medications
• The large subset of treated patients with elevated NTproBNP, a marker of cardiac distress, showed larger reductions, with an 86% relative risk reduction for cardiac death equivalents and a 24% relative risk reduction for non-fatal MACCE. Diminished.
• A follow-on Phase III study in a highly responsive patient population with FDA-approved NTproBNP elevation (CardiAMP HF II) was initiated and positive interim results were validated

SUNNYVALE, Calif., March 4, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, today announced a Phase III announced positive interim results of the trial. CardiAMP randomized controlled trial^® Autologous cell therapy (CardiAMP HF) in 110 randomized patients with advanced chronic heart failure with a mean follow-up of 20 months. The results showed reductions in cardiac death equivalents and MACCE, and the reductions were even greater in patients with elevated NTproBNP, a common marker of cardiac distress. This data was presented today at the Technology and Heart Failure Therapeutics (THT) 2024 Annual Meeting by Amish Laval, MD, Director of Cardiovascular Clinical Research and Professor of Medicine at the University of Wisconsin-Madison.

Over an average follow-up of 20 months, patients with advanced chronic heart failure who received a single endocardial dose of autologous CardiAMP cell therapy while receiving maximal medical therapy had a relative risk of all-cause cardiac death equivalent of 37%; Relative risk decreased by 9%. Relative risk reduction in the incidence of nonfatal heart attack, stroke, and hospitalization for heart failure (MACCE). Patients treated with CardiAMP cell therapy had nearly 5% lower odds of equivalent cardiac death over up to 2 years compared to control patients treated with heart failure drugs alone (8.3% vs. 13.2%, respectively). CardiAMP cell therapy was also associated with a reduction in ventricular tachyarrhythmias, enhanced cardiac function as measured by left ventricular ejection fraction, and a trend toward improvement in NTproBNP.

In a subgroup analysis of patients with elevated NTproBNP at baseline (including 59% of all randomized patients enrolled), patients treated with CardiAMP cell therapy had an 86.2% relative risk of equivalent cardiac death. experienced a relative risk reduction of 23.9% in MACCE. These patients had more than 17% lower odds of equivalent cardiac death up to 2 years than control patients treated with heart failure drugs alone (2.9% vs. 21.1%, respectively).

“These positive results with CardiAMP cell therapy are very encouraging, especially for patients with elevated NTproBNP, which includes the majority of heart failure patients we see in our daily practice,” said Laval, co-principal investigator of the trial. said the doctor. “The trial’s Data and Safety Monitoring Board determined that the trial would not meet the composite primary endpoint, including 6-minute walk distance, in accordance with the study design, but would not meet the composite primary endpoint, which included reduction in cardiac death equivalents, reduction in MACCE, and safety. The positive results demonstrate the potential of this therapy to improve outcomes in patients with advanced chronic heart failure. Despite improvements with current drugs and devices, heart failure remains an epidemic, and we currently have an exciting opportunity for treatments to improve important objective outcomes such as mortality and readmission rates. We are excited to be part of a great team that will test the potential of this therapy in this highly responsive population in a follow-on trial that is now FDA-approved and will soon begin treating the first patients. ”

“We thank the FDA for its expedited review and approval of this important follow-on Phase III trial. We are encouraged by the overall picture of today’s results and look forward to the final 24-month data analysis and subsequent trial results. We expect both to be consistent with this very positive data,” said Peter Altman, CEO of BioCardia.

The THT Scientific Meeting also reported initial enrollment in the dose-escalation safety phase of BioCardia’s Phase I/II study of CardiALLO™ allogeneic mesenchymal stem cell (MSC) therapy in patients with heart failure. The cohort that received the lowest dose of 20 million cells started without any adverse events, arrhythmias, rejection, or allergic reactions occurring during treatment. The study’s lead author is R. David Anderson, M.D., professor of medicine at the University of Florida, Gainesville. Following completion of the dose-escalation safety phase of the study, a phase II randomized, double-blind, controlled trial is planned to assess efficacy.

About BioCardia cardio amplifier Autologous cell therapy program*

Designated as a breakthrough therapy by the FDA, CardiAMP cell therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart through a minimally invasive, catheter-based procedure to stimulate the body’s natural healing response. There is likely to be. CardiAMP cell therapy incorporates three unique elements not previously utilized in investigational cardiac cell therapies. Preoperative cell analysis for patient selection, high targeted doses of cells, and a unique delivery system proven to be safer than other intramyocardial delivery systems. And it achieves dramatic success in cell retention. The CardiAMP HF trial is supported by the Maryland Stem Cell Research Fund and receives reimbursement from the Centers for Medicare and Medicaid Services (CMS) for both treatment and management procedures. The CardiAMP HF II trial is expected to similarly secure CMS reimbursement.

About BioCardia Cardiallo Allogeneic cell therapy program*

CardiALLO allogeneic cell therapy provides “off-the-shelf” mesenchymal stem cell therapy, typically obtained from young donors. These cells are immunomodulatory and have been shown to release multiple important angiogenic factors that can influence inflammatory processes in heart failure and enhance microvascular function and capillary networks in ischemic tissues. It has been. His CardiALLO therapy for heart failure uses BioCardia’s new MSC manufacturing process. This process builds on the experience of his three completed MSC clinical trials with co-sponsors that included 84 patients treated with the same delivery platform for the same indication.

*CardiAMP and CardiALLO therapies are considered investigational and are limited to investigational purposes only by U.S. law.

about biocardia

BioCardia, Inc., headquartered in Sunnyvale, California, develops cells and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. CardiAMP autologous cell therapy and CardiALLO allogeneic cell therapy are the company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide proprietary biotherapy delivery systems and preclinical and clinical development services for biotherapy delivery to the heart.

Forward-looking statements

This press release contains forward-looking statements that are subject to a number of risks and uncertainties. Forward-looking statements include, but are not limited to, whether the final 24-month analysis and subsequent trial results will be consistent with the interim results presented herein as expected and whether CardiAMP HF II will receive CMS reimbursement as expected; and whether CardiAMP HF II verifies it. Interim data results from CardiAMP HF and statements regarding our intentions, beliefs, projections, prospects, analyzes or current expectations. Such risks and uncertainties include, among other things, the development of new products or technologies, regulatory approvals, unanticipated expenditures and obtaining additional funds necessary to continue pursuing BioCardia’s business and product development plans. including inherent uncertainties related to the ability to do business, and overall market conditions. These forward-looking statements are made as of the date of this press release, and BioCardia undertakes no obligation to update any forward-looking statements.

“believe”, “estimate”, “anticipate”, “expect”, “plan”, “intend”, “may”, “could”, “might”, “will” , and may use terms such as “should.” We identify these forward-looking statements by the use of “approximately” or other words that convey uncertainty as to future events or results. Although the Company believes that it has a reasonable basis for each forward-looking statement contained herein, forward-looking statements are not guarantees of future performance and the Company’s actual results may differ from this press release. Please note that forward-looking statements contained herein may differ materially. release. Factors that may cause or contribute to such differences include, but are not limited to, our liquidity position and ability to raise additional financing, and our ability to successfully advance our clinical trials. . As a result of these factors, there can be no assurance that the forward-looking statements in this press release will prove to be accurate. Other factors that could materially affect actual results are described under the heading “Risk Factors” in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 29, 2023; as set forth in subsequently filed Quarterly Reports on Form 10-Q. . BioCardia expressly disclaims any intention or obligation to update these forward-looking statements, except as required by law.

Media contact:
Michelle McAdam
michelle@chronic-comm.com, 310-902-1274

Investor contact information:
David McClung, Chief Financial Officer
investors@biocardia.com, 650-226-0120